银柴退热颗粒的质量标准研究

Study on Quality Standard of Yinchai Tuire Granules

目的建立银柴退热颗粒的质量标准。方法采用薄层色谱(TLC)法对银柴退热颗粒中的柴胡、黄芩、金银花、连翘、紫花地丁、大青叶进行定性鉴别;采用高效液相(HPLC)法对银柴退热颗粒中绿原酸、连翘酯苷A、黄芩苷进行含量测定,色谱柱为Hypersil BDS C18150mm×4.6mm,5μm,流动相为乙腈-0.1%甲酸水溶液梯度洗脱,体积流量为0.7mL/min,柱温为30℃,进样量为10μl,检测波长为330nm。结果6种药材的TLC供试品色谱与对照品或对照药材在相应位置上呈现相同颜色斑点或荧光斑点。绿原酸、连翘酯苷A、黄芩苷的线性范围分别为:2.67~267μg/mL、3.57~357μg/mL、8.04~804μg/mL,精密度、稳定性、重复性的RSD均<3.0%,平均回收率分别为:102.88%、102.13%、104.02%,平均含量分别为:0.79mg/g、1.48 mg/g、5.01 mg/g。结论建立的银柴退热颗粒质量标准稳定可靠,重复性好,可用于制剂的质量控制和评价。

Objective To establish the quality standard for Yinchai Tuire Granules.Methods TLC was used for qualitative identification of Lonicera japonica Flos,Scutellaria baicalensis Georgi,Bupleuri Radix,Forsythiae Fructus,Viola yedoensis and Folium Isatidis in Yinchai Tuire Granules.HPLC method was used for the content determination of Chlorogenic acid,Forsythoside A and Baicalin in Yinchai Tuire Granules.Using Hypersil BDSC18 column(150 mm×4.6 mm,5μm).Gradient elution of acetonitrile-0.1%formic acid solution was used.The volume flow rate is 0.7 mL/min.The column temperature is 30℃.The detection wavelength was 330 nm.Cluster analysis was carried out on the results.Results TLC test sample chromatogram of 6 medicinal materials showed the same color spot or fluorescence spot at the corresponding position with the reference substance and control medicinal materials.The linear range of glucose,Chlorogenic acid,Forsythoside A and Baicalin were 2.67~267μg/mL,3.57~357μg/mL,8.04~804μg/mL.RSD of precision,stability and repeatability were all less than 3.0%.The average recovery rates were:102.88%,102.13%and 104.02%.The average content was 0.79 mg/g,1.48 mg/g and 5.01 mg/g.Conclusion The quality standard of Yinchai Tuire Granules is stable,reliable and repeatable,which can be used for quality control and evaluation of preparation.